The present invention relates to a container for use in sterilizing an object and to a method for sterilizing an object. The apparatus and method of the present invention are particularly suitable for use in sterilizing medical and surgical equipment.
Surgical operations must be carried out under strict conditions of sterility to minimize infection risk in the patient. To this end, a sterile field is set up in the operating theatre around the patient. Any theatre staff, such as surgeons or nurses, who have to touch the patient during surgery must rigorously scrub and wear sterile surgical gloves. All instruments and equipment used in the surgery must also be sterile.
Surgical equipment is frequently supplied inside sterile packaging which ensures that the equipment inside the packaging is sterile and remains so whilst the packaging remains unopened. However, storage, handling and distribution of the packaging causes the outer surface of the packaging to become non-sterile. To account for this whilst maintaining the sterile field in the operating theatre, surgical teams include a non-sterile nurse who opens the packaging of pieces of surgical equipment and exposes the sterile equipment to a nurse within the sterile field. The nurse within the sterile field then removes the sterile equipment from the packaging. Provided that the non-sterile nurse does not touch the equipment, sterility of the sterile field is not compromised.
A number of pieces of medical and surgical equipment are re-usable. In order to re-use such equipment, it is necessary to sterilize the equipment before use in the next operation. Sterilization of medical and surgical equipment is commonly carried out in an autoclave in which steam at elevated pressure and a temperature of around 134xc2x0 C. sterilizes the equipment.
Although autoclaving is an effective sterilizing method, difficulties can arise when it is desired to sterilize delicate medical and surgical equipment. In particular a number of pieces of equipment are typically loaded into the autoclave at a time, which can lead to breakage of delicate equipment. Moreover, it can be difficult to maintain sterility of the equipment when it is removed from the autoclave and stored for use in the next operation.
Other methods of sterilisation that are frequently used include exposing the medical apparatus to a sterilising gas, such as ethylene oxide or STERAD, or soaking in a cold sterilizing liquid.
Endoscopic or laparoscopic surgery, also commonly known as key-hole surgery, is become more wide spread. Endoscopic and laparoscopic techniques are low invasive techniques that can dramatically reduce the duration of stays in hospitals by patients. Endoscopic and laparoscopic techniques require the use of telescopes (hereinafter called xe2x80x9cendoscopic telescopesxe2x80x9d for convenience) to enable the surgeon to see the site of the surgery on a monitor. Endoscopic telescopes comprise an elongated body in the form of a thin tube having an enlarged housing at one end thereof, which housing contains optical components and allows coupling to a camera or video feed. The other end of the endoscopic telescope is inserted into the patient via an incision made in the patient""s skin. The endoscopic telescope projects into the sterile field and hence the endoscopic telescope must be sterilized.
It is an object of the present invention to provide a method for and an apparatus for use in sterilizing an object such as a piece of medical or surgical equipment.
In one aspect, the present invention provides a method for sterilizing an object comprising placing the object into a container, the container having an opening through which the object is inserted, the container having at least a portion which is adapted to be collapsed or deformed, closing the opening with a vapour permeable closure and placing the container in a sterilizing environment for sufficient time to sterilize the object.
Preferably, the vapour permeable membrane is a water vapour permeable membrane.
Preferably, the vapour permeable membrane is also permeable to liquid water.
Preferably, the vapour permeable membrane is permeable to other liquids, such as sterilizing liquids.
Preferably the step of placing the container in a sterilizing environment includes the step of placing the container in an autoclave and operating the autoclave for sufficient time to sterilize the object. Although autoclaving is the preferred sterilizing method, other sterilizing methods may be used. Such methods may include placing the container in a sterilizing fluid. In such cases, the closure should also be permeable to the sterilizing fluid.
The step of closing the opening of the container preferably comprises the step of affixing a vapour-permeable closure to a rim of the opening. The closure may be affixed to the rim of the opening by an adhesive. The closure may comprise any suitable vapour permeable material. Preferably, the material is also permeable to other fluids, such as gases. However, it is preferred that the closure material does not allow the passage of bacteria therethrough.
In another embodiment, the step of closing the opening comprises placing a lid or cover on or over the opening, which lid or cover includes at least a portion which is permeable to vapour. The lid or cover is preferably a tamper-evident lid or cover that can only be removed from the container in a tamper-evident manner. Such tamper-evident lids or covers are well known and will not be described further.
The closure material may comprise a microporous membrane. More preferably, the closure material comprises a paper or paper-based material. It will be appreciated that the closure material should be resistant to failure under the sterilizing conditions used. For example, a thermoplastic material that melts at a temperature below the temperature used in an autoclave is unsuitable for use in the present invention if autoclaving is to be used to obtain sterilization. A suitable membrane material could be TYVEK, a proprietary material manufactured by DuPont. This would be suitable for use in the STERAD system. Other materials could also be used.
By placing the object in a container and closing the opening in the container, the object is protected from damage by contact with other objects during sterilization by virtue of the object being protected by the container. The closure confines the object within the container and prevents the entry of bacteria into the container after sterilization is complete. Thus, the container also provides a convenient storage container that can maintain sterility of the object.
In another aspect, the present invention provides a container for use in. sterilizing an object, the container being adapted to receive the object, the container having a first end having an opening to allow positioning of the object in the container, a second end located generally opposite the first end and wherein at least a portion of the container is adapted to be collapsed or deformed whereby the first end and the second end are moved relatively towards each other.
Preferably, at least a portion of the container near the first end is collapsible or deformable whereby collapsing or deforming of the collapsible or deformable portion causes the first end to move relatively closer to the second end.
Preferably, the container includes an elongated portion for receiving an elongate object.
Preferably, the container is relatively enlarged at the open end. This allows easier insertion of the object into the container. It also enables the container to hold objects having a relatively enlarged part, for example, such as an endoscopic telescope. Preferably, the container is adapted to contain a piece of medical or surgical equipment, more preferably an elongated medical apparatus, most preferably an endoscopic telescopic.
Preferably, the opening in the first end of the container is sealable by a vapour-permeable closure. The vapour-permeable closure may be affixed to the rim of the opening in the first end to thereby close the opening. The vapour permeable closure may be removed from the open end by peeling. The vapour permeable closure may comprise a paper or paper-based material or a microporous material.
The vapour permeable membrane is preferably a water vapour permeable membrane. The vapour permeable membrane is preferably permeable to liquid water.
In another embodiment, the open end of the container may be closed after insertion of the object to be sterilized has been inserted therein by placing a lid or cap on the open end, which lid or cap includes a vapour-permeable portion. Preferably, the lid or cap is a screw-on lid or cap that has a threaded portion that co-operates with a complementary threaded portion formed on the container. Alternatively, the lid or cap may be a pop-on type.
The lid or cap is preferably provided with a tamper-proof seal or a tamper evident seal. It is especially preferred that the lid cannot be removed from the container after it has been fitted. If the closure is removed, it should be apparent that it has been removed and that sterility has been compromised. Preferably, removal of the closure damages the closure such that it cannot be re-applied to the container.
The lid or cap may be provided with a vapour-permeable portion by forming the lid or cap with an opening and covering the opening with a vapour-permeable material. The vapour permeable material may comprise a paper or paper-based material or a microporous material. Alternatively, the lid or cap may be manufactured from a vapour-permeable material.
The second end of the container may be formed as a closed end. More preferably, the second end of the container is closed by a vapour permeable means. This allows air to circulate through the container after autoclaving to thereby assist in drying any condensed water inside the container. The vapour permeable means may be a paper or paper-based closure means or a microporous material. In embodiments where the second end is a closed end and is formed from the material of the container, one or more vapour-permeable windows may be provided in the container. Indeed, one or more vapour-permeable windows may be provided even if the second end has a vapour-permeable closure thereon.
In one embodiment of the present invention, the container comprises a first portion and a second portion joined together. The first portion may include the first end and the second portion may include the second end. The first and second portions are preferably formed from plastics material and may be joined by any suitable method, such as welding. The first portion may contain the deformable or collapsible portion, or the second portion may contain the deformable or collapsible portion. Alternatively, both the first portion and the second portion may contain a collapsible or deformable portion.
The container is most preferably designed for use in the sterilization of endoscopic telescopes. In this embodiment, the container has an elongated part into which the endoscopic telescope is inserted and an enlarged portion depending from the elongated part for holding the enlarged part of the telescope. It is preferred that the elongated part has the deformable or collapsible portion. This may be provided by having corrugations or flutes formed in the outer wall(s) of the elongated part. Other arrangements that lead to a collapsible or deformable portion may also be used.
In a most preferred embodiment of the container embodiment for use in sterilizing endoscopic telescopes, the container comprises a first part and a second, elongated part joined to the first part. The first part is of relatively enlarged diameter (with respect to the elongated part). The first part may include an outwardly projecting part having an open end that fits relatively snugly with the second, elongated part such that the outwardly projecting part of the first part overlaps with a part of the second elongated part. The overlapping parts may be joined together, eg, by welding (or by any other joining technique). In this fashion the overlapping parts may reinforce each other and provide greater strength to the elongated part of the container.
A part of the container may be provided with indicating means to indicate whether or not the container has been exposed to a sterilising environment. The indicating means may be a colour change portion that undergoes a colour change when exposed to the sterilising environment. The colour change may be caused by exposure to elevated temperature or the sterilising gas. Preferably, the indicating means forms part of the vapour permeable closure.
The container of the present invention provides a container for containing a piece of medical or surgical equipment during sterilization. The container protects the medical or surgical equipment from damage during sterilization. By closing the open end of the container with the vapour permeable closure, sterilization of the medical or surgical equipment can be achieved and the medical or surgical equipment can be stored in sterile conditions inside the container following sterilization. The container may include indication means to indicate if the container has been sterilised. The indicator means is preferably a replaceable vapour permeable closure.
Moreover, the provision of a collapsible or deformable portion allows the equipment inside the container to be easily accessed during a surgical operation. In particular, in use in a surgical operation, the non-sterile nurse removes the closure and then collapses or deforms the collapsible or deformable portion of the container. Consequently, the sterile piece of medical or surgical equipment inside the container is at least partially exposed and the sterile nurse can grasp the exposed part and remove the sterile equipment from the container. The container of the present invention allows the sterilized equipment to be removed therefrom without the non-sterile nurse having to touch the sterile inner part of the container and the sterile equipment inside the container. The sterile nurse does not have to touch the non-sterile outer surface of the container.
The collapsible or deformable portion of the container is preferably made to collapse or deform in a concertina fashion. To this end, the collapsible or deformable portion may include a plurality of fold lines or lines of weakness extending around the container. It will be appreciated that the present invention also includes any other collapsible or deformable portion. For example, the container may include a portion made from a pliant material or include a portion able to be folded back upon itself, or include a corrugated or fluted portion.
The collapsible or deformable portion may comprise a portion of the container at or adjacent to the first end of the container which is adapted to fold downwardly upon the container. This action will move the first and second ends relatively closer together.
The container may be made from any material that is resistant to the conditions encountered in sterilization. The container is preferably made from suitable plastics material. Polyetheylene is particularly preferred. The container may be made in one piece or it may be made from two or more pieces joined together. Containers of varying size may be made to accommodate telescopes or other instruments of varying size. The inside surface of the container is preferably hydrophobic or treated to be hydrophobic. The container may also be gamma-ray permeable to leave open the possibility of using in gamma-ray sterilization.
In another aspect, the present invention provides a container for use in sterilizing an object, the container adapted to receive the object, the container having an internal volume for receiving the object, and an opening through which the object can be inserted into the container, characterized in that the container is adapted to be separated into at least two parts to thereby expose the object.
Preferably, the container has a first end and a second end and a portion of the container between the first end and the second end is adapted to be breakable to thereby enable separation of the container into at least two parts. The breakable portion may comprise one or more lines of weakness, or a portion made of a low-breaking point material.
The container is preferably provided with a closure means to close the opening in the container. The closure means is preferably a tamper proof or tamper-evident closure. More preferably, the closure means cannot be removed from the container once it has been fitted thereto. If the closure means is removed, it should be apparent that the closure means has been removed, to thereby indicate that sterility has been compromised.
The container preferably has a vapour permeable portion. The vapour permeable portion may be part of the container, or it may be part or all of the closure.
The vapour permeable portion may be as described with reference to the other aspects of the invention described herein.
The closure means may be as described with reference to the other aspects of the present invention.
In this aspect of the invention, the container with an object inside is sterilized. After sterilization, use of the container in an operating theatre requires the non-sterile nurse to grasp the object in both hands and break the container into the at least two portions. The sterile nurse can then remove the object from the portion that still holds the object.
In all aspects of the present invention, the container may further comprise a sheet-like material adapted to drape over the object upon removal of the object from the container. The sheet-like material may be mounted to the inside of the container. Alternatively, the sheet-like material may be mounted to the closure means. The sheet-like material is preferably a sheet of gauze or other medical fabric. By draping over the object as it is removed from the container, the sheet-like material provides a further barrier between the object and the non-sterile part of the container to further reduce the chance of compromising sterility